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Methods for a multicenter randomized trial for mixed urinary incontinence
Rationale and patient-centeredness of the ESTEEM trial
Sung, V. W., Borello-France, D., Dunivan, G., Gantz, M., Lukacz, E. S., Moalli, P., Newman, D. K., Richter, H. E., Ridgeway, B., Smith, A. L., Weidner, A. C., Meikle, S., & Pelvic Floor Disorders Network (2016). Methods for a multicenter randomized trial for mixed urinary incontinence: Rationale and patient-centeredness of the ESTEEM trial. International Urogynecology Journal, 27(10), 1479-1490. https://doi.org/10.1007/s00192-016-3031-7
INTRODUCTION AND HYPOTHESIS: Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months.
METHODS: ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment.
RESULTS: The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized.
CONCLUSIONS: We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.
